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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in pharmacovigilance regulatory reporting processes, including ICSR submissions and reconciliation, while effectively collaborating with multidisciplinary teams. Proficient in Argus for generating safety reports and managing deviations and CAPAs.
Highest-signal resume keywords
Pharmacovigilance Regulatory ReportingICSR Submission MonitoringArgus ReportingPeriodic Safety ReportsC1 Level English
ATS Keywords
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Hard Skills
ICSR ReconciliationData MigrationProcess Documentation UpdatesCAPA ManagementPQ Testing
Soft Skills
Independent WorkCollaborative Teamwork
Tools & Technologies
Microsoft Office SuiteArgus
Industry Keywords
PharmacovigilanceLife Science DegreeE2B Profiles
About the role
Key responsibilities & impact- Adhere to pharmacovigilance regulatory reporting processes and instructions
- Monitor scheduled expedited and non-expedited ICSR submissions and exchanges daily
- Execute monthly ICSR reconciliation reports with PV clients and safety partners
- Assist in testing gateway-to-gateway submissions to health authorities and ICSR exchanges
- Create and close submissions-related deviations and associated CAPAs
- Generate Argus-based line listings and summary tabulations for Periodic Safety Reports
- Assist with generating and verifying custom periodic reporting
- Assist with setup and verification of Periodic Safety Report requirements
- Coordinate, develop, and maintain pharmacovigilance reporting services with the management team
- Perform PQ testing for multi-tenant Argus upgrades, patches, custom projects, and data migration imports
- Execute process and documentation updates for territory-specific and custom E2B profiles
Requirements
What you’ll need- Post-secondary education or equivalent professional work experience (life science degree preferred)
- C1 level of English
- 2 years of proven experience in a similar role
- Proficient computer knowledge, specifically Microsoft Office Suite (Outlook, Word, Excel)
- Computer keyboarding skills
- Ability to work independently and collaboratively in a multidisciplinary team
Benefits
Comp & perks- Remote working support
- Hybrid working encouraged for new hires within a reasonably short commute of an office, as agreed with the manager
- Equal opportunity workplace
- Diversity, equity, and inclusion commitment